by Ellen Chappelka, William Lazonick, and Ken Jacobson
At the beginning of May 2021, it was reported that millions of doses of the Johnson & Johnson COVID vaccine, approved for emergency use in the United States, had been contaminated at the Maryland plant run by contract manufacturer Emergent BioSolutions. A few weeks earlier, the reputation of Emergent for unreliable product quality had already led AstraZeneca to reject the use of its plant to manufacture 100 million doses of the Oxford vaccine in partial fulfilment of a U.S. government procurement contract. In mid-June, AstraZeneca was still in talks with another U.S. contract manufacturer, Catalent, to gain access to some of its capacity to produce the 100 million doses.
Especially since the U.S. government will likely export the Oxford/AstraZeneca vaccine to less developed nations that desperately need it, Emergent’s inability to deliver a high-quality product accentuates the extent to which reliable production processes are critical to the availability of vaccines needed to bring the pandemic under control. The causes of Emergent BioSolutions’ manufacturing failure: the company’s inferior management and the inept biomanufacturing workers it employed.
The successes of the COVID-vaccine rollout thus far could not have been achieved without an adequate supply of qualified manufacturing labor possessing the experience to ensure high rates of high-quality throughput on the production lines. The rollout has relied on the skills and commitment of the employees to scale, at breakneck speed, the mass manufacture of novel products using some novel technologies. As Catalent’s vice president of marketing and strategy, Bernie Clark, observed in January 2021: “To keep adding capacity and new lines, you have to have the people to run them.” Training a new biomanufacturing engineer, however, can take years. When COVID-vaccine production commenced, in some cases as early as May 2020, the readily available experts were quickly recruited by the manufacturing partners of the leading vaccine developers.
Prior to the coronavirus pandemic, the bioprocessing field was already bereft of skilled workers. In 2018, it was estimated that 40 percent of the biotechnology industry was unable to hire an adequate number of biomanufacturing engineers to meet its need at the time. Obviously, the pandemic has made that need all the more acute. Even with sound manufacturing management in place, the consequences of this supply-chain bottleneck are already evident: Moderna, for example, has had to delay the delivery of its Q2 obligations to Canada and Britain of 1-2 million doses because of worker shortages at the plant in Visp, Switzerland, of Lonza, its largest manufacturing partner.
To date, most of Lonza’s Moderna vaccine for delivery to the U.S. market has been produced at its plant in Portsmouth, New Hampshire, just 90 minutes away from Moderna’s headquarters in Norwood, Massachusetts. But the contract with Switzerland-based Lonza, signed on May 1, 2020—more than seven months before the Moderna vaccine would actually be approved for use—calls for one production line in Portsmouth and three in Visp, with 60-70 suitably educated workers per line. That has proven to be an underestimate: The notoriously fickle mRNA must be produced in small, labor-intensive batches, for which more workers per line have been required.
The supply of these highly educated, experienced workers with specialized certifications that demonstrate a minimum level of knowledge in the biomanufacturing field, such as Good Manufacturing Process (GMP), will be stretched even thinner in the future. Lonza and Moderna have agreed to double the number of production lines in Switzerland from the initial three, scheduled to be fully operational by June 2021, to six by June 2022. Furthermore, in June 2021, Lonza and Moderna announced an expansion of their production through the addition of three manufacturing lines at Lonza’s Geleen, Netherlands, plant.
To upstaff these production lines Lonza has shifted workers from other manufacturing contracts, reached out to other pharmaceutical companies for additional personnel and—with the assistance of the Swiss government—developed partnerships with other large regional manufacturers. Notably, the Swiss food giant Nestlé was tapped by the government in late April 2021 to assign workers to spend three months at Lonza production facilities. While Nestlé employees do not have direct bioengineering experience, their general industrial know-how is a valuable resource that allows workers with more highly specialized experience to be employed by Lonza more directly in the vaccine-manufacturing process.
Obviously, it is difficult for Lonza, as it is for all contract manufacturing organizations, to find biomanufacturing engineers. There are few in the career field or in the pipeline, and there is no feasible way of quickly scaling the quantity of these skilled specialists. For high-quality mass production—in this case, of safe and effective COVID vaccines—these specialty employees must have advanced degrees in their fields as well as years of experience in the pharmaceutical industry. The Swiss government has already expedited the visas for qualified foreign nationals to increase the number of workers with the technical know-how to work with mRNA processes at companies based in Switzerland.
Halfway through 2021, there is every indication that the worker shortage has a created a major constraint on the COVID-vaccine rollout, especially for those parts of the world that, unlike the United States, do not have surplus doses. There is a desperate need for national policy makers, global civil-society organizations, and biopharma industry officials to focus on investments that would add capacity to the pipeline of biomanufacturing workers. It is concerning that an industry so critical to the health and well-being of billions is so chronically understaffed that there is no flux capacity producing vital vaccines while also continuing the production of other manufacturing lines.
To prepare for future pandemics, the United States government must commit to further funding and expanding the development of biomanufacturing workforce via investments in the nation’s higher education system. Texas A&M already has a model program through its Center for Innovation in Advanced Development and Manufacturing, which is producing COVID-19 vaccine doses for Novavax. This program could serve as a blueprint for universities around the nation and world. To deal with this pandemic and prepare for the next one, the United States must provide the higher education and continuous work experience to a far larger supply of biomanufacturing personnel than was the case before SARS-CoV-2 caused disease and death around the globe.